MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM


Device Classification Name

shunt, central nervous system and components

510(k) Number K022554
Device Name MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Original Applicant
INTEGRA NEUROSCIENCES
311 enterprise dr.
plainsboro, 
NJ 
08536

Original Contact donna wallace
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 08/02/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No